Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K840756 |
Device Name |
BIOPATCH BOVINE PERICARDIAL PATCH |
Applicant |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
103 BAUER DR. |
P.O. BOX 530 |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
ANTHONY C PARKS |
Correspondent |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
103 BAUER DR. |
P.O. BOX 530 |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
ANTHONY C PARKS |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 02/23/1984 |
Decision Date | 02/08/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|